Conflicts of interest in research may occur when outside financial interests compromise, or have the appearance of compromising,
the professional judgment of a researcher when designing, conducting, or reporting research.
In 2011, the Public Health Service (PHS) released revised financial conflict of interest (FCOI) regulations
(42 CFR 50) that apply
to any institution receiving funds from a PHS entity. The OU PHS FCOI policy and the implementation plan corresponds with the mandate of this new regulation.
OU's PHS FCOI POLICY IS AVAILABLE HERE
According to the federal reporting requirements the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research must submit a FCOI disclosure form at the time of application, within 30 days of acquiring or discovering a new SFI, and annually after the Notice of Award. If there is insufficient space to include all your SFI's in one report please submit a second report with those relationships that did not fit in the first submission.
Submit a disclosure form here: http://ors.ou.edu/fcoi/fcoireport.asp
According to the federal requirements all PHS-funded “Investigators” at OU must complete the online FCOI training which is available here: https://www.citiprogram.org/. Successful completion
of the training is required prior to the expenditure of funds on any newly-funded projects, including noncompeting continuation awards. This applies
to all PHS-sponsored research projects as of August 24, 2012. Training must be completed at least every four years. Current PHS awards are not subject
to these new requirements until the noncompeting continuation is awarded.
New users to the CITI program must create an account. The same CITI account can be used for both the FCOI requirement and OU's IRB training requirement.
Investigator, for the purposes of this policy, means the Principal Investigator and any person listed by the Principal Investigator as responsible
for the design, conduct, or reporting of their sponsored program(s). These individuals are listed at the time of proposal submission.
Normally, all senior research personnel should be listed as “Investigators.” All of the following should be considered, to the extent they are responsible
for the design, conduct, or reporting of the sponsored program: professorial faculty, research associates, emeritus faculty, research collaborators, visiting
scientists, post-docs, GRAs, or students.
PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to:
- Agency for Healthcare Research and Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control and Prevention (CDC)
- Food and Drug Administration (FDA)
- Health Resources and Services Administration (HRSA)
- Indian Health Service (IHS)
- National Institutes of Health (NIH)
- Office of Global Affairs (OG)
- Office of the Assistant Secretary for Health (OASH)
- Office of the Assistant Secretary for Planning and Evaluation
- Office of the Assistant Secretary for Preparedness and Response (ASPR)
- Office of Public Health and Science
- Substance Abuse and Mental Health Services Administration (SAMHSA)
Inquiries about the NIH FCOI regulation for grants and cooperative agreements may be directed to: VPRFCOI@ou.edu